QUESTO HUB
QUESTO HEALTHCARE ECOSYSTEM
Clinical Pharmacology & Maternal-Fetal Drug Safety Center
Labetalol
UNII Code
1GEV3BAW9J
RxNorm CUI
896762
Prescribing & Clinical Reference: Compiled from official regulatory labeling (US FDA PLLR, NIH LactMed®, EMA). Clinical decisions during pregnancy and lactation require individualized patient assessment and physician consultation.
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Review infant exposure and nursing considerations before administration.
Drug Levels in Breast Milk & Relative Infant Dose
Relative Infant Dose (RID)
Indexed in Clinical Studies
RID <10% is generally considered low by clinical guidelines.
Milk Concentration & Transport
Evaluated in human/animal pharmacokinetic models.
3. Females & Males of Reproductive Potential
FDA Labeling Section 8.3 — Pregnancy Testing, Contraception & Infertility
Pregnancy Testing
Standard pre-treatment clinical assessment as indicated.
Contraception & Washout
Review contraception duration based on drug elimination half-life.
Infertility Considerations
No significant drug-induced impairment reported in standard models.
4. Regulatory Source Provenance & Comparison
Direct attribution to official regulatory documents without synthesized consensus
| Regulatory Organization | Jurisdiction | Document / Framework | Effective Date | Official Source Link |
|---|---|---|---|---|
|
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
|
United States | regulatory_label | 2026-05-22 | Official Record |
|
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
|
European Union | regulatory_label | Recent | Official Record |
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
United States
Framework:
regulatory_label
Effective Date:
2026-05-22
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
European Union
Framework:
regulatory_label
Effective Date:
Recent